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Re: I-Glow post# 183269

Monday, 02/17/2020 11:31:42 AM

Monday, February 17, 2020 11:31:42 AM

Post# of 203908
The clinical trials cost around $45 million? Total BS. Not when the company is smart like OWCP to do the trials in Israel for a fraction of the cost!

Oh, did you know OWCP's patented Psoriasis cream has already passed its Safety trial successfully...less than 200K?

Glad I can help with the cost again. smile

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Per following report, it seems Israel is already in the group of countries that FDA works with their clinical trials!

And we know the OWCP Skin Disorder cream has already completed its Safety Trial successfully!

"FDA Perspective on International Clinical Trials


Kassa Ayalew, M.D., M.P.H.
Acting Branch Chief
Division of Good Clinical Practice Compliance
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research Food and Drug Administration


Clinical trials are increasingly conducted outside US

What Drives Companies to Conduct Clinical Trials Outside the USA?

Leveraging Knowledge and Resources

Utilize finite resources strategically and efficiently, leverage inspection resources ( Observe each other inspection, conducting joint inspection, provide parallel advice to sponsors, participate in regular discussions)
Share knowledge and information (inspection reports)
European Medicines Agency (EMA), European National Inspectorates, Health Canada, Japan’s PDMA, Korea’s KFDA, China’s SFDA, Singapore’s HAS, Argentina’s ANMAT, New Zealand, South Africa, Israel, India, Jordan, Thailand


https://www.fda.gov/media/87406/download




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